PEAK Research
PEAK Research
Acute abdominal pain (tummy ache) accounts for 6-10% of all emergency department (ED) visits in children. Some of these children will be diagnosed with appendicitis, which is inflammation inside the gut that often requires surgery to fix. It takes time to diagnose appendicitis and kids may need treatment for their pain while they are waiting.
In this study we are trying to determine if ketorolac (a strong NSAID) works as well as morphine (an opioid) to help treat abdominal pain for kids in the ED. Both medications are already commonly used in Canadian EDs to help treat pain, but there has not been a study comparing the two for abdominal pain specifically. We also want to see if ketorolac has fewer side effects when compared to morphine.
This study is being conducted in four children’s hospitals across Canada, and we will ask a total of over 500 children to be part of this study. Approximately 125 of these children will be recruited from the Stollery Emergency Department.
Site lead: Dr. Samina Ali
Research coordinator: Raymond Odsen
Study team: Dr. Mohamed Eltorki (PI), Dr. Waleed Alqurashi, Dr. Quang Ngo, Dr. Evelyne D. Trottier, Karen Beattie, Kathryn Birnie, Dr. Jason Busse,, Dr. Michael Livingstone, Dr. Naveen Poonai, Dr. Yaron Finkelstein, Dr. Stephen Freedman, Dr. Lehane Thabane, Dr. Graham Thompson. University of Alberta research nurses: Amanda Hack, Kevin Chung, Joy Ylagan, Ella Milne
Funding: CIHR
Canada-UK AI Study: Using Artificial Intelligence-Enhanced Social Robots to Improve Children's Healthcare Experiences
Children experience pain and distress in clinical settings every day. The negative consequences of unaddressed pain can be both short-term (e.g. fear, distress, inability to perform procedures) and long-term (e.g. needle phobia, anxiety). Working with stakeholders, we will develop a robust, adaptive, socially intelligent robot designed to distract children during painful clinical procedures, thereby reducing pain and distress. We interviewed health care professionals, caregivers and children about how they feel a robot can help children better manage painful procedures. We are currently developing this robot with the information we learned from these interviews. Our final step will be to test the robot's effectiveness through a clinical trial. It is a collaborative effort spanning six universities in Canada, two universities in the United Kingdom, and three branches of science (healthcare and biomedical sciences, social science and humanities, and natural sciences and engineering).
National Principal Investigators: Dr. Samina Ali (Canada), Dr. Mary Ellen Foster (UK)
Canadian Project Manager: Patricia Candelaria
Healthcare and Biomedical Sciences: Dr. Sasha Litwin, Dr. Jennifer Stinson, Dr. Jennifer Parker, Dr. Christine Chambers, Summer Hudson, Cynthia Nguyen, Lauren Harris, Fareha Nishtat,
Social Sciences and Humanities: Dr. David Harris, Dr. Frauke Zeller, Lauren Dwyer
Natural Sciences and Engineering: Dr. Ron Petrick, Dr. Andres Ramirez-Duque, Dr. Alan Lindsay
University of Alberta Research Assistants: Neelam Mabood, Taytem Syrnyk, Joshua Eszczuk
Publications:
Foster ME, Ali S, Litwin S, Parker J, Petrick R, Smith D, Stinson J, Zeller F. (2020). Using AI-Enhanced Social Robots to Improve Children’s Healthcare Experiences. 10.1007/978-3-030-62056-1_45.
GIRL PEM: Gender Impact on Research Leadership and Productivity in Pediatric Emergency Medicine: cross-sectional and mixed-method studies by the Pediatric Emergency Research Canada (PERC) network.
Women’s achievements in medicine are often perceived differently than those of men. This is caused by implicit gender bias and leads to differences in opportunities. Literature suggests that men have higher research productivity, different career trajectories, and greater funding opportunities than women. Speaking with women in academic medicine, we have learned that biased hiring policies, informal social network and unprofessional behaviours are widely experienced. Few studies have examined gender differences in emergency medicine research productivity in Canada.
The field of emergency medicine research in Canada lacks a deep understanding of the role of gender within its professional networks. This study will provide Canadian data detailing the impact of gender on research productivity and researchers' personal opinions and experiences regarding the gender gap.
This study combines two projects: (1) an analysis of the research produced by our PERC's members, and (2) an analysis of PERC member's perceptions and experiences of how personal attributes have affected their research careers.
The results of this work will inform recommendations to support women researchers whose career progress is impacted by bias.
Principal investigators: Dr. Stevi Golden-Plotnik (co-PI), Dr. Gabrielle Freire (co-PI)
Study team: Dr. Samina Ali (mentor), Dr. Nathalie Gaucher, Dr. Angela Jarman, Dr. Kelly Cobey, Dr. Amy Plint, Dr. Roger Zemek, Rebecca Emerton, Kelly Kim, Ally Suarez, Tayte Syrnyk
Funding: Canadian Association of Emergency Physicians
CAN-PREPARE: Canadian Anaphylaxis Network- Predicting Recurrence after Emergency Presentation for Allergic Reaction
Food allergy impacts 1-in-2 Canadian households, and up to 80% of severe allergic reactions in children are triggered by food. In Canada, approximately every 10 minutes, there is an Emergency Room (ER) visit for food-induced allergic reaction. In the event of an allergic reaction, treatment guidelines recommend that children be transported by an ambulance to an ER for observation, even if symptoms are mild or have stopped. The rationale behind the need for observation in the ER is that some patients are at risk of delayed reactions which can be life-threatening. Unfortunately, research data on the frequency, timing, severity, and predictors of delayed allergic reactions are very limited. As a result, many children are also admitted to the hospital or observed in the ER for long hours to increase the chance of detecting delayed reactions.
Canadian families described feelings of ambiguity about the severity of a reaction and hesitance to treat with epinephrine along with perceptions that ER visits often involve a long post-treatment wait time. The unpredictability of reactions and anticipation of ER visits can have a significant psychosocial impact on children and their caregivers. In fact, surveys of Canadian families showed that almost half of respondents described their anxiety level as 8 out of 10 or higher.
The main objective of this study is to determine which combination of risk factors identify children with allergic reactions who are at risk of developing delayed reactions. From this knowledge, we can develop guidelines so that children at high risk are monitored appropriately, whereas those at no or low risk can be discharged from the ER once they have no symptoms.
Site lead: Dr. Andrew Dixon
Research coordinator: Raymond Odsen
Study team: Dr. Waleed Alqurashi (PI), Dr. Amy C. Plint, Dr. Jocelyn Gravel, Dr. Grace Bravo, Dr. Stephen Freedman, Dr. Suzanne Schuh, Dr. Mohamed Eltorki
Research assistants: Neelam Mabood, Taytem Syrnyk, Joshua Eszczuk
Funding: CIHR
HIKO-STEC: Hyperhydration to Improve Kidney Outcomes in Children with Shiga Toxin-Producing E. coli Infection: A Multinational Embedded Cluster Crossover Randomized Trial
Hemolytic Uremic Syndrome (HUS) is a serious complication of high-risk Shiga toxin-producing Escherichia coli (STEC) infection and the most common cause of acquired acute kidney injury in otherwise healthy children. STEC is commonly aquired from tainted meat, but there are other ways to get it. HUS develops in up to 1 in 5 children after a STEC infection, 60% of whom require temporary kidney dialysis; and about 3-5% of children die from HUS.
The primary objective of the study is to determine if early intravenous fluids (hyperhydration) in children diagnosed with STEC infection improves clinical outcomes compared with drinking fluid only, which is the current practice.
Site lead: Dr. Andrew Dixon
Research coordinator: Raymond Odsen
Study team: Dr. Stephen Freedman, Dr. David Schnadower, Dr. Phillip Tarr
Funding: NIAID
PRoMPT BOLUS: PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis
Sepsis is a medical emergency caused by infection. More than 25 million children worldwide are diagnosed with sepsis every year. Sepsis is the most expensive hospital condition in North America and for critically ill children it is the most common cause of hospital death.
Children with sepsis need treatment in the Emergency Department (ED) with IV fluids to improve blood supply to vital organs in the body. Two types of IV fluids are commonly available and used in EDs and hospital wards for treating children with sepsis: balanced fluids (BF) and 0.9% “normal” saline (NS). However, there is currently no research that clearly shows which IV fluid is the most effective and safest type to use.
The purpose of this large, international study is to compare the effectiveness (how well the fluids work) and safety of the two most commonly used types of IV fluid (BF vs NS) to improve clinical outcomes in children treated for sepsis. We will also determine whether one type of fluid is more cost-effective.
The PRoMPT BOLUS study is a multi-national clinical trial that includes 3 large pediatric emergency medicine research networks: Pediatric Emergency Research Canada (PERC), Pediatric Emergency Care Applied Research Network (PECARN – United States) and Paediatric Research in Emergency Departments International Collaborative (PREDICT – Australia/New Zealand). This study is being conducted in thirteen children’s hospitals across Canada, and we will ask between 1400 and 2700 Canadian children to be part of this study. Approximately 350 of these children will be recruited from the Stollery Emergency Department.
Site lead: Dr. Sarah Curtis
Research coordinator: Raymond Odsen
Study team: Dr. Graham Thompson (PI), Beata Mickiewicz (PM), Dr. Fran Balalmuth, Dr. Scott Weiss, Dr. Stephen Freedman, Dr. Pavan Judge, Dr. Ahmed Mater, Dr. Karen Gripp, Dr. April Kam, Dr. Gurinder Sangha, Dr. Gary Joubert, Dr. Adrienne Davis, Dr. Anupam Sehgal, Dr. Waleed Alqurashi, Dr. Fuad Alnaji, Dr. Yasaman Shayan, Dr. Simon Berthelot, Dr. Jason Emsley, Dr. Myla Moretti, Dr. Tex Kissoon, Dr. Bram Rochwerg, Dr. Suzette Cooke
Funding: CIHR
Publications:
Weiss SL, Balamuth F, Long E, Thompson GC, Hayes KL, Katcoff H, Cook M, Tsemberis E, Hickey CP, Williams A, Williamson-Urquhart S, Borland ML, Dalziel SR, Gelbart B, Freedman SB, Babl FE, Huang J, Kuppermann N; Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT Networks. PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial. Trials. 2021 Nov 6;22(1):776. doi: 10.1186/s13063-021-05717-4. PMID: 34742327; PMCID: PMC8572061.
POPCORN: Pediatric Outcomes Improvement through Coordination of Research Networks: COVID-19 Platform Prospective Cohort Study
The overall objective of the POPCORN Platform is to prepare Canadian child health researchers and their networks to respond rapidly and cohesively to the current and future pandemics or to any child health issues of importance, using COVID-19 as the proof-of-concept. More specifically, POPCORN aims to:
Integrate the entire follow-up of a child across its healthcare trajectory, starting with COVID-19 and expanding to other child health-related issues;
Determine indirect consequences of COVID-19 response measures on child health; and
Build human capital, infrastructure, and expertise for a pediatric research-ready platform to enable network investigators to attract additional funding.
POPCORN is funded by the Canadian Institutes of Health Research (CIHR) to establish a research platform that will monitor COVID-19 infections, vaccinations, and the social impacts among children and youth.
Site lead: Dr. Bruce Wright
Research coordinator: Andrea Eaton
Study team: Dr. Caroline Quach (PI), Dr. Fiona Muttalib, Dr. Srin Murthy, Dr. Stephen Freedman, Dr. Ahmed Mater, Dr. Geert t’Jong, Dr. Rishi Ganesan, Dr. Gita Wahi, Dr. Shaun Morris, Dr. Anupam Sehgal, Dr. Maala Bhatt, Dr. Jesse Papenburg, Dr. Fatima Kakkar, Dr. Arnaud Gagneur, Dr. Marc-André Dugas, Dr. Jennifer Foster, Dr. Cheryl Foo
Research assistants: Neelam Mabood, Taytem Syrnyk, Joshua Eszczuk
Funding: CIHR
Qualitative Study of health literacy and its impact on decision making in the PED
Caregivers play a pivotal role in making health decisions for their children, drawing on factors such as their knowledge, values, beliefs, and cultural background. An important aspect influencing their decision-making is health literacy, which is the ability to gather, understand, and apply health information within a healthcare context. Low health literacy is associated with increased healthcare visits and poorer overall health outcomes. Caregivers with limited health literacy may overestimate the seriousness of their child's illness, leading to overuse of pediatric emergency departments for non-urgent issues. This project aims to understand the motivations behind caregivers seeking care for non-urgent conditions in Alberta pediatric emergency departments, with a focus on the impact of health literacy on their decision-making. By gaining insights into the factors influencing caregivers decision-making when seeking non-urgent medical care, we aim to develop strategies to better support caregivers at home, ultimately reducing unnecessary visits to the pediatric emergency department.
Principal Investigators: Dr. Katharine Jensen (trainee), Dr. Samina Ali (supervisor)
Co-investigators: Dr. Michael Van Manen, Dr. Keon Ma, Dr. Graham Thompson
Patient Partner: Julie Leung
Decision-maker Partner: Dr. Tania Principi, Dr. Andrew Dixon
Research Assistants: Neelam Mabood, Taytem Syrnyk, Joshua Eszczuk
Funding: TRIP, AMA
Emergency Department Patient-Activated Transition from Care to Home (ED-PATCH)
Understanding and remembering important health information during an emergency department (ED) visit can be challenging for patients and caregivers. ED-PATCH is a new tool designed to help. Given to patients early in their ED visit, it allows them to track key information—like diagnosis, tests, treatments, medications, and follow-up instructions—in real time.
Before leaving the ED, patients review their notes with a care provider to confirm accuracy. The final summary can be printed or sent electronically, supporting better understanding and ongoing care.
Over five years, our team will evaluate how ED-PATCH affects patient recall, experience, and communication. We will also explore how best to implement it in real-world emergency settings across Canada.
Site Investigator: Dr. Bruce Wright
Research coordinator: Andrea Eaton & Nadia Shular
Study PI: Dr. Janet Curran, IWK Halifax
Funding: CIHR
Anxiolysis for laceration repair in children: An open-label multicenter adaptive trial (ALICE)
Lacerations (or cuts) make up nearly half of all procedures done on kids who visit the emergency room. Research shows that children often feel a lot of stress and anxiety when they get stitches, even when a numbing cream, called LET (lidocaine-epinephrine-tetracaine), is used. If a child's stress and anxiety isn't treated, it can lead to fear of needles and fear of medical care later in life. The American Academy of Pediatrics recommends treating pain and distress as much as possible, but because there isn’t enough research, no single anxiolytic (calming medication) method is used regularly.
In the emergency department, medications like midazolam and nitrous oxide are often used as the calming medications during laceration repair. A newer medication, called dexmedetomidine, could be helpful for calming children during stitches. Right now, we just don’t know which of these three medicines is the best choice for kids getting stitches. This is important because many children get stitches and experience distress. Our results may be used to help such children have a better healthcare experience in the future.
Site Investigator: Dr. Samina Ali
Research coordinator: Pat Candelaria
Study team members: Dr. Naveen Poonai (PI), Vinolia Arthur-Hayward (PM); University of Alberta Nurses: Kevin Chung, Amanda Hack, Taytem Syrnyk, Joy Ylagan
Funding: Accelerating Clinical Trials (ACT), Academic Medical Organization of South Western Ontario (AMOSO), Western Strategic Support for Success (WSSS), New Frontiers in Research Fund (NFRF)
BIPED: A randomized controlled trial comparing epinephrine and dexamethasone to placebo in the treatment of infants with bronchiolitis
Bronchiolitis, a viral infection of the lungs, is the most common reason for infants to be admitted to hospital in higher resourced countries. In the United States alone, 100,000 infants are admitted yearly to hospital at a cost of $1.73 billion. In Canada, 35 out of every 1,000 infants younger than one year of age are admitted to hospital yearly for an estimated cost of $23 million. Currently, national and international guidelines recommend only supportive care (such as oxygen or fluids) for the management of infants with bronchiolitis. Research by our team however has suggested that combined therapy with steroids and epinephrine (adrenaline) may reduce admissions to hospital. While other clinical and basic science studies support CanBEST’s findings, our results suggesting synergy from combined treatment raised considerable controversy. Doctors are uncertain that the effects found in one study are enough to change practice. They are also uncertain of the safety of the relatively long course of high dose steroids used in the previous study.
This study will compare treatment with inhaled epinephrine and 2-day course of oral steroid (dexamethasone) to placebo for infants with bronchiolitis. We hope to show that this treatment will lead to less children needing admission to hospital.
Site lead: Dr. Andrew Dixon
Research coordinator: Raymond Odsen
Study team members: Dr. Amy Plint (PI), Kristina Vogel (PM), Dr. Serge Gouin, Dr. Gary Joubert, Dr. Scott Sawyer, Dr. Graham Thompson, Dr. Andrew Dixon, Dr. Stuart Dalziel, Dr. Chris Lash, Dr. Alex Wallace, Dr. Meredith Borland, Dr. Simon Craig, Dr. Amit Kochar; University of Alberta research nurses: Amanda Hack, Kevin Chung, Joy Ylagan, Ella Milne.
Funding: CIHR
Publications:
Lan J, Plint AC, Dalziel SR, Klassen TP, Offringa M, Heath A; Pediatric Emergency Research Canada (PERC) KIDSCAN/PREDICT BIPED Study Group. Remote, real-time expert elicitation to determine the prior probability distribution for Bayesian sample size determination in international randomised controlled trials: Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone (BIPED) study. Trials. 2022 Apr 11;23(1):279. doi: 10.1186/s13063-022-06240-w. PMID: 35410375; PMCID: PMC8996198.
Children and their caregivers often have high levels of stress, fear, frustration, and uncertainty while waiting for medical care in the emergency department (ED) waiting room. Our team’s earlier research has shown that using robots to provide distraction during medical procedures, such as IV insertions, lessens child distress. We have also shown that robots providing caregiver education and distraction in ED waiting rooms reduces caregiver anxiety and improves their satisfaction with care, but there is little research specifically directed at decreasing child fear and stress in the waiting room. A positive waiting room experience can shape a family’s entire medical journey, as it is often their first point of contact with the healthcare system.
In this study, we plan to employ a humanoid robot, specially programmed to deliver brief, psychology-based interventions and distraction, to improve children’s experiences in the ED waiting room. The robot will distract children with music and dance and engage the child in guided relaxation techniques without any direct touch (minimizing infection risks). Robot interaction will be provided on certain days and on other days, children will have a ‘typical’ waiting room experience without robot presence. Through surveys, we will determine if the robot interaction helps lessen child fear and pain, and improve child (as well as caregiver and triage nurse) satisfaction with the waiting room experience. We will compare children’s experiences on days with and without a robot. We expect that children who experience robot interaction in the waiting room will report less fear, compared to those children who have a ‘typical’ no-robot waiting room experience.
Principal Investigators: Patricia Candelaria, Dr. Samina Ali
Co-Investigators: Dr. Summer Hudson, Dr. Elise Kammerer, Stephanie Smook, Julie Leung, Rebecca Liedtke, Jennifer Woods, Dr. Maryna Yaskina
Research Assistants: Neelam Mabood, Taytem Syrnyk, Joshua Eszczuk
Funding: ARNET
Vomiting (“throwing up”) and diarrhea from viral infections (acute gastroenteritis or “stomach bug”) are the most common symptoms affecting children. Staying hydrated by drinking small amounts of liquids often is the most important treatment parents and caregivers can give to their children. Sometimes, vomiting still continues to happen, even when small amounts of liquids are given.
In this study, we are trying to learn more about the ideal use of ondansetron (Zofran) in children who are treated for vomiting from acute gastroenteritis (stomach bug). The purpose of the study is to determine if the use of multiple doses of ondansetron compared with placebo, provided for use at home, results in less severe symptoms and prevent the need to return to the emergency department. We will measure how children are feeling, and ask about parent/caregiver satisfaction with the study medication.
This study is being conducted in six children’s hospitals across Canada, and we will ask a total of over 1000 children to be part of this study. Approximately 250 of these children will be recruited from the Stollery Emergency Department.
Site lead: Dr. Andrew Dixon
Research coordinator: Patricia Candelaria
Study team: Dr. Stephen Freedman (PI), Sarah Williamson-Urquhart (PM), Dr. Darcy Beer, Dr. Amy Plint, Dr. Serge Gouin, Dr. Gary Joubert, Dr. Terry Klassen, Tannis Erickson, Dr. Anna Heath, Dr. Chris McCabe, Dr. Yaron Finkelstein, Petros Pechlivanoglou, Erin Kirwin, David Rios; University of Alberta research nurses: Andrea Eaton, Amanda Hack, Calvin Kruger, Alyssa Lord, Lily Lu, Smit Patel
Funding: CIHR
Publications:
Heath A, Rios JD, Williamson-Urquhart S, Pechlivanoglou P, Offringa M, McCabe C, Hopkin G, Plint AC, Dixon A, Beer D, Gouin S, Joubert G, Klassen TP, Freedman SB; PERC-KIDSCAN DOSE-AGE Study Group. A pragmatic randomized controlled trial of multi-dose oral ondansetron for pediatric gastroenteritis (the DOSE-AGE study): statistical analysis plan. Trials. 2020 Aug 24;21(1):735. doi: 10.1186/s13063-020-04651-1. PMID: 32838813; PMCID: PMC7445935.
Freedman SB, Williamson-Urquhart S, Heath A, Pechlivanoglou P, Hopkin G, Gouin S, Plint AC, Dixon A, Beer D, Joubert G, McCabe C, Finkelstein Y, Klassen TP; KidsCAN-Pediatric Emergency Research Canada (PERC) Innovative Pediatric Clinical Trials DOSE-AGE Study Group. Multi-dose Oral Ondansetron for Pediatric Gastroenteritis: study Protocol for the multi-DOSE oral ondansetron for pediatric Acute GastroEnteritis (DOSE-AGE) pragmatic randomized controlled trial. Trials. 2020 May 27;21(1):435. doi: 10.1186/s13063-020-04347-6. PMID: 32460879; PMCID: PMC7251709.
Ketodex Trial: Intranasal dexmedetomidine plus ketamine for procedural sedation in children: an adaptive randomized controlled non-inferiority multicenter trial
Orthopedic injuries account for more than 10% of ED visits in children. Further, 25 to 50% of children will sustain a fracture before age 16 years. Forearm fractures account for 20-32% of fractures in children, making them the most common fracture type. Between 20 and 40% of extremity fractures in children require a closed reduction (non-surgical setting of the bones), which means the child will need to be made sleepy, or receive procedural sedation and analgesia (PSA).
Intravenous (IV) ketamine is the most commonly used medicine to make a child sleepy for a closed reduction. However, children rate IV insertion as the most painful hospital experience, second only to the injury itself. IV insertion can be more technically difficult in children because of smaller veins and lack of cooperation, often leading to multiple IV attempts.
A combination of intranasal (IN) dexmedetomidine plus IN ketamine (called Ketodex) may provide effective sedation for children who need a a closed reduction without the distress and pain related to IV insertion. A less painful experience has been found to decrease anxiety, and improve satisfaction and the family’s relationship with the health care team.
There are 6 participating pediatric emergency departments recruiting for this study across Canada. We will recruit about 400 children to be part of this study.
Site lead: Dr. Samina Ali
Research coordinator: Patricia Candelaria
Study team members: Dr. Naveen Poonai (PI), Dr. Kamary Coriolano (PM), Dr. April Kam, Dr. Darcy Beer, Dr. Maala Batt, Dr. Quynh Doan, Dr. Vikram Sabhaney, Dr. Terry Klassen, Tannis Erickson; University of Alberta research nurses: Andrea Eaton, Amanda Hack, Calvin Kruger, Alyssa Lord, Lily Lu, Smit Patel
Funding: CIHR
Publications:
Poonai N, Coriolano K, Klassen T On behalf of KidsCAN PERC iPCT-SPOR (Innovative Paediatric Clinical Trials – Strategy for Patient Oriented Research) Ketodex Study Team, et al. Adaptive randomised controlled non-inferiority multicentre trial (the Ketodex Trial) on intranasal dexmedetomidine plus ketamine for procedural sedation in children: study protocol. BMJ Open 2020;10:e041319. doi: 10.1136/bmjopen-2020-041319
Heath A, Rios JD, Pullenayegum E, Pechlivanoglou P, Offringa M, Yaskina M, Watts R, Rimmer S, Klassen TP, Coriolano K, Poonai N; PERC-KIDSCAN Ketodex Study Group. The intranasal dexmedetomidine plus ketamine for procedural sedation in children, adaptive randomized controlled non-inferiority multicenter trial (Ketodex): a statistical analysis plan. Trials. 2021 Jan 6;22(1):15. doi: 10.1186/s13063-020-04946-3. PMID: 33407719
AMPLE: Anaphylaxis Management: Policies, Laws Evaluation
Anaphylaxis is a severe type of allergic reaction that can sometimes be fatal if not treated. Around 8% of Canadian (almost 3.5 million) have a food allergy and are at risk of anaphylaxis. Food-induced anaphylaxis has also doubled in the last decade among Canadian children presenting to the emergency department (ED).
Prior research has shown that fatal anaphylaxis is associated with reliance on the sole use of oral antihistamines/steroid and not administering epinephrine within the first hour following reaction. A significant number of anaphylaxis reaction take place at school (25%) and legislation like Alberta's Bill 201 have mandated that epinephrine auto-injectors (EAIs, eg. EpiPen) be stocked at schools.
The purpose of this study is to evaluate the effect of policies/laws on pre-hospital EAI use. This is a cross-Canada study reviewing thousands of charts and using the previously established Cross-Canada Anaphylaxis REgistry (C-CARE).
Site lead: Dr. Andrew Dixon
Research coordinator: Raymond Odsen
Study Team: Dr. Moshe Ben-Shoshan, Greg Shand, Ella Milne
Limb injuries, such as broken arms and legs, are a very common cause for Emergency Department (ED) visits for children with pain, and they are known to cause moderate to severe pain in most children. However, previous research shows that children's pain in the ED is still under-treated. Further, children are less likely to receive appropriate pain medicine than adults with similar injuries. The purpose of this research study is to figure out which pain medicine or combination of pain medicines works best for the pain management of children with limb injuries. The pain medicines we are studying are ibuprofen (Advil/Motrin), acetaminophen (Tylenol/Tempra), and hydromorphone (Dilaudid).
This study will consist of 2 trials that will be run at the same time. Families with a child with an acute limb injury will decide which trial they wish to participate in: the Opioid trial or the Non-Opioid trial. If they select the Non-opioid trial, they will receive either (a) Ibuprofen OR (b) Ibuprofen and acetaminophen. If they select the Opioid trial, they will receive either (a) Ibuprofen OR (b) Ibuprofen and acetaminophen OR (c) Ibuprofen and hydromorphone. Regardless of which study they choose, their child will, at minimum, receive Ibuprofen (Advil/Motrin) for their pain.
There are 6 participating children’s emergency departments recruiting for this study across Canada.
National Study lead: Dr. Samina Ali (PI)
National Project Manager: Patricia Candelaria
Study team members: Dr. Naveen Poonai, Dr. Scott Sawyer, Dr. Serge Gouin, Dr. Maala Batt, Dr. Antonia Stang, Dr. Lawrence Richer, Dr. Christopher McCabe, Dr. Terry Klassen, Tannis Erickson, Dr. Maryna Yaskina, Dr. Amy Drendel, Dr. Martin Offringa, Dr. Petros Pechlivanoglou, Erin Kirwin; University of Alberta research nurses: Andrea Eaton, Amanda Hack, Calvin Kruger, Alyssa Lord, Lily Lu, Smit Patel
Funding: CIHR
Publications:
Ali S, Rajagopal M, Klassen T, Richer L, McCabe C, Willan A, Yaskina M, Heath A, Drendel AL, Offringa M, Gouin S. Study protocol for two complementary trials of non-steroidal or opioid analgesia use for children aged 6 to 17 years with musculoskeletal injuries (the No OUCH study). BMJ open. 2020 Jun 1;10(6):e035177.
Heath A, Yaskina M, Hopkin G, Klassen TP, McCabe C, Offringa M, Pechlivanoglou P, Rios JD, Poonai N, Ali S. Non-steroidal or opioid analgesia use for children with musculoskeletal injuries (the No OUCH study): statistical analysis plan. Trials. 2020 Dec;21(1):1-7.
Ali S., Hopkin G., Poonai N. et al. A novel preference-informed complementary trial (PICT) design for clinical trial research influenced by strong patient preferences. Trials 22, 206 (2021). https://doi.org/10.1186/s13063-021-05164-1
IMAGINE Survey: Child and family preferences for distraction modalities to reduce procedural pain and distress in the emergency department
In this study, we are trying to figure out which distraction tools children and their caregivers prefer to use to help their children’s procedural pain and distress. Many children visiting the Emergency Department (ED) need to have minor medical procedures that can cause pain, such as having an intravenous (IV) line placed. These medical procedures can be a stressful experience for both children and their parents, so we are trying to find ways to make this experience better for families.
We are trying to find better ways to help children with their pain and anxiety when they need to have a minor medical procedure done in the ED. One thing we can do to help a child is distract them with toys or games. This helps to take their attention away from the source of the pain and anxiety. We would like to use this information to help future families that come into the ED by figuring out which distraction tool works the best in reducing pain and stress.
This study is being conducted in three children’s hospitals across Canada, and we will ask a total of 500 parents and 200 children to be part of this study. Approximately 300 of these participants will be recruited from the Stollery ED.
Principal investigators: Dr. Elise Kammerer, Dr. Samina Ali
Research coordinator: Patricia Candelaria
Study team: Dr. Naveen Poonai, Dr. Evelyne D. Trottier, Rebecca Liedtke, University of Alberta Research Assistants: Madelyn Coughlan, Neelam Mabood, Taytem Syrnyk
Funding: Canadian Association of Emergency Physicians
The Virtual Reality Trial: A randomized controlled trial of virtual reality-based distraction for venipuncture-related pain and distress in children
Intravenous (IV) insertions are a very common procedure among children who visit the Emergency Department. IV insertions, like other needle procedures, can often be a painful and stressful experience for both children and their families. Untreated pain and distress can further lead to a scared and uncooperative child, a need for repeated IV attempts, and overall dissatisfaction with care for the family.
We are trying to find better ways to help children who need to have painful procedures such as IV insertions. One thing we can do to help a child is distraction. Distraction therapy aims to take a child's attention away from the source of the pain and anxiety and re-direct it to more positive things. Some examples of distraction include watching videos, listening to music or stories, playing with toys or, in the case of this study, virtual reality (VR) googles. The VR googles will use computer technology to produce an artificial 3D video or game that the child can watch and interact with during the IV procedure. The purpose of our research study is to determine if distraction using virtual reality can help reduce a child's pain and distress related to having an IV insertion.
We have completed recruitment for this study and are now preparing the manuscript for publication.
Principal Investigators: Manasi Rajagopal, Dr. Samina Ali,
Study team members: Summer Hudson, Megan MacNeil, Patricia Candelaria, Madelyn Coughlan, Neelam Mabood, Taytem Syrnyk
Funding: WCHRI Innovation
Publication:
Ali S, Rajagopal M, Stinson J, Ma K, Vandermeer B, Felkar B, Schreiner K, Proctor A, Plume J, Hartling L. Virtual reality-based distraction for intravenous insertion-related distress in children: a study protocol for a randomised controlled trial. BMJ Open. 2022 Mar 30;12(3):e057892. doi: 10.1136/bmjopen-2021-057892. PMID: 35354617; PMCID: PMC8968513.